Special population precautions and medication guidelines for Bayer Zydus version of Darolutamide in India
The use of Darolutamide in special populations requires adjusting the dosage or strengthening monitoring according to individual circumstances, while also paying attention to drug interactions and specific risks of adverse reactions. The following provides a detailed explanation of medication and precautions for special populations.
1. Medication for special populations
(1) Pregnant women: Based on animal studies showing embryotoxicity, it is contraindicated during pregnancy. Women of childbearing age should take effective contraceptive measures during medication and one week after discontinuation.
(2) Breastfeeding period: It is not clear whether the medication is secreted into the breast milk. It is recommended to suspend breastfeeding during the treatment period.
(3) Children: Safety and efficacy have not been established, and it is not recommended for patients under 18 years old.
(4) Elderly patients: Patients over 65 years old do not need to adjust their dosage, but due to possible complications, the risk of adverse reactions may increase and monitoring needs to be strengthened.
(5) Liver function impairment: Mild to moderate impairment does not require dose adjustment; Patients with severe damage (Child Pugh C grade) should use caution and closely monitor liver function.
(6) Renal dysfunction: No dose adjustment is required for all degrees of renal dysfunction, including patients with end-stage renal disease.
2 Medication precautions
(1) Administration method: It should be taken with food to improve bioavailability, and is recommended to be taken with meals.
(2) Drug interactions: Avoid co administration with potent CYP3A4 inducers (such as rifampicin), as it may lead to a decrease in blood drug concentration and affect efficacy.
(3) Neurological monitoring: Although the incidence of epilepsy is low (<0.5%), patients with a history of epilepsy still need to use it with caution.
(4) Fall prevention: May cause fatigue and dizziness, elderly patients should pay special attention to fall prevention measures.
(5) Laboratory monitoring: Regular liver function checks are required during treatment, especially for patients with concomitant liver disease.
(6) Skin reaction: If there is a severe rash or allergic reaction, the medication should be stopped immediately and medical attention should be sought.
Disclaimer：《Special population precautions and medication guidelines for Bayer Zydus version of Darolutamide in India》Edited and sorted by Seagull Pharmacy's editors. Please contact us in time if there is any infringement. In addition, the suggestions for drug usage, dosage and disease mentioned in the article are only for medical staff's reference, and can not be used as any basis for medication！